04/22 2016

How the FDA’s UDI Mandate Benefits Hospitals When Paired with UHF RFID Technology

Among providers and suppliers, there is a fairly consistent understanding about how the Unique Device Identifier (UDI) mandate from the FDA is impacting the way medical devices (class III, II and I) are already being labeled or are going to be labeled by 2018. We know, for example, that by 2018 all medical devices in hospitals will be labeled with a product identifier, a lot or serialized number, and a standard expiration date.

Many healthcare professionals, however, are unsure about what it means for hospitals and how they can take advantage of it for the improvement of their own operations. Most providers are looking forward to having products come through their supply chain that will adhere to standard labeling that will increase their ability to track and recall products as well as document them with better accuracy at the point of care, thereby improving electronic medical records. Nevertheless, many hospitals have doubts that they, as an organization with their different systems, whether for materials management, clinical documentation, billing or patient records, are really capable of handling UDI-compliant data.

At VUEMED’s Focus Group held recently at the IDN Summit in Orlando, representatives of diverse hospitals and hospital groups shared their internal struggles and lack of awareness about the efficiency possibilities and quality improvements that UDI adoption inside their organizations could provide them with. UDI has the ability to improve transactions throughout the supply chain from the manufacturers all the way to the patients, by providing manufacturers with a means to track individual units from their labelling stage all the way to their customers and beyond if they pair such standards with the right reporting technology. For hospitals, it provides a standard that they could adopt to track each SKU and within each SKU, each unit, from the point of entry to the point of use in their MMIS, clinical documentation, and billing systems, using the same unique identifier.

This is an incredible opportunity to finally standardize documentation and reporting throughout the hospital. Today, because there are so many systems using different ways to identify the same product, having the capability to mine the data and follow a product throughout the supply chain all the way to the procedure room is very challenging and full of obstacles. It is a vast undertaking for hospitals to normalize their product IDs throughout all their systems. UDI offers such a unique chance to capitalize on a standard that flows from the FDA all the way to the patient and beyond.

The main problem remains the ability to leverage the UDI, once implemented, throughout the healthcare supply chain. This is where there is a need to ensure that the UDI can be captured efficiently and accurately in all the systems that require supply data for one purpose or another. The FDA is promoting adoption of UDI standards through the use of barcodes and RFID, either one of which can adequately capture the information. The use of barcodes, however, depend on human intervention to scan a product, and as subject to human compliance prone to errors.

Could RFID be the technology solution that, when paired with UDI standards, transforms the healthcare supply chain and product usage documentation? It certainly allows hands-free capture and tracking of individual units with uncompromised accuracy. Most participants at our Focus Group were excited at the prospect of a standards-based solution that would automate documentation and make data mining very easy with full correlation between systems on products. They admitted that although RFID seems to be the most effective manner to improve their supply chain operations and clinical documentation using UDI standards, there is a lack of incentive within their organizations due to the fact that there is no mandate forcing hospitals to act, which thus leaves the decision to embark on such a transformation journey in the hands of their executive teams. They felt that there needs to be greater awareness about the tremendous benefits that a UDI compliant RFID solution offers hospitals.

Learning that manufacturers are actively engaging in RFID and becoming educated about the tremendous ROI opportunities for hospitals seem to be two critical factors in advancing such a project. Adoption by manufacturers is a critical factor as it places the burden on tagging products on them and makes it easier for hospitals to consider an RFID-driven UDI capture solution. Many misconceptions about RFID were brought forth including, safety, limitations, and cost. Learning that the FDA has approved RFID technology in healthcare and the differences between High Frequency and Ultra High Frequency technologies as well as the differences between passive and active RFID were important pieces of information for participants when thinking over the realm of possibilities for their own organizations.

Not all RFID technologies are equal. UHF passive Gen2 RFID technology offers a more flexible and scalable approach than any other as it is not confined to specialized cabinets and can seamlessly track consumables, assets and people. The cost element was critical too, and given that an UHF passive Gen2 RFID installation represents a fraction of the cost of alternate RFID technologies, as well as provides a much more attractive ROI, was a very important consideration for the Focus Group participants.

11/18 2015

Adopting Global Standards for the Supply Chain

In October our CEO, Arnold Chazal, participated in the 5th GS1 Supply Chain Week in Australia. Here are some of his reflections…

1) The adoption of global standards and effective technology is essential for tracking medical devices and products throughout the healthcare supply chain, from the point of manufacture to the point of use in a patient procedure.

2) Healthcare is global in nature since products are manufactured and used in all parts of the world. It is essential for manufacturers to adhere to labeling standards such as GTIN by GS1 that enables the unique and unequivocal identification of products on a global basis. The GS1 standards also include pedigree information such as lot or serial number and expiration date which are all critical for the supply chain and for patient safety. From the caregiver’s standpoint it enables mechanisms to be put in place to track recalled products and expired items and avoid their utilization in patient procedures. From the supply chain standpoint it allows manufacturers to track their products with accuracy, manage their stock (especially consigned inventory), and prevent waste by being proactive about the management of supplies that are approaching expiration.

3) The GTIN standard is available to manufacturers for their products in both barcode format and RFID encoding. VUEMED is GS1 compliant and has developed technologies that are standards-based, including EPC and UDI. The FDA’s Unique Device Identification (UDI) regulation relies on established global standards such as HIBCC and GS1 to meet its labeling requirements using a barcode or RFID medium. Manufacturers doing business in the U.S. will have to be fully compliant for Class 1, 2, and 3 medical devices by 2018. This mandate coming from the US is rapidly affecting the rest of the world. Three-quarters of the largest manufacturers of medical devices are based in the U.S., and all major manufacturers do business in the U.S. Regardless of where products are manufactured it makes sense financially and logistically for these manufacturers to adopt a UDI-compliant standard for labeling their medical devices instead of different labeling standards in different regions of the world. GS1 as a standard seems to be very popular outside the U.S. and some government and health agencies are mandating that products be labelled following the GS1 standard in order to be sold in their markets.

4) Such standards are good for the supply chain as they allow for consistency throughout the supply chain from manufacturer to hospital. It helps bridge the data gap by supporting adoption of a single manner to identify a product that can be used across the hospital in all its systems, from materials management systems, to clinical documentation systems, electronic medical records systems and billing systems. Also such standards promote more comprehensive data collection that include lot number and expiration date that can easily be collected from the product package and recorded in these systems. The main issue is that most systems that the hospitals use are not prepared to handle the collection of such data or read such barcodes or RFID tags. This is where VUEMED provides solutions that track products from manufacturer to patient with complete, accurate and swift data capture, which in turn is populated in all desired hospital systems, enhancing medical records, billing and procurement systems.


09/30 2015

FDA’s UDI Regulations – Friend or Foe?

At the IDN Summit last week, we held a focus group with supply chain and value analysis experts at leading hospitals from around the country about the impact of the FDA’s Unique Device Identification (UDI) regulation.  We talked about how this regulation, which was initially seen by many as a nuisance that was going to principally affect manufacturers, is already improving the quality of patient care and outcomes, particularly where it is being implemented using RFID technology at hospitals.  Terrie Reed of the FDA as well as Pam Kennedy, Director of Clinical Contracting at Beth Israel Deaconess Medical Center (BIDMC), participated remotely as guest facilitators.  Pam, whose organization is partnering with VUEMED and dozens of manufacturers to achieve UDI compliance, shared her experiences and gave many examples of how UDI implementation through RFID is enabling manufacturers as well as BIDMC to avoid waste, track recalled and expiring devices instantly, and achieve just-in-time par levels due to better predictive analysis.  Participants discussed how manufacturers typically have very poor data and control over the items they have under consignment, problems which will disappear once they use UDI-compliant RFID tags on their devices.  Inventory management will be automated and guesswork will be removed through real-time, accurate information.  Participants also talked about the inability of manufacturers to trace their devices; thus, when one gets returned to them for whatever reason, the manufacturers would rather dispose of the item than restock it somewhere else and run the risk associated with a product whose history and chain of custody information are unknown.  The ability to track the exact location and movements of medical devices with near 100% accuracy due to advanced UHF RFID technology is already helping the healthcare industry save money, avoid waste, and improve clinical outcomes.  For more information about VueTrack-UDI, our new global standards-based RFID solution for enabling manufacturers and hospitals to become UDI compliant, click here.

03/16 2015

Pros & Cons of Mobile Devices for the Supply Chain

I was recently interviewed about the pros and cons of mobile/portable electronic devices for the healthcare supply chain in hospitals.  As I stated, the emphasis should really be on the whole solution, not just one component of it such as whether the device is mobile or not.  The solution is what drives the efficiency in the supply chain, and is usually a combination of sophisticated software and hardware that may be mobile/portable; however, portability is not necessarily the best hardware option in the hospital environment.  It is true that because the supply chain extends all the way to the procedure room and the patient, smart phones and tablet PCs may seem attractive due to their format and portability; however, their inherent physical limitations – namely their limited screen size – can constrain the full potential of the app or software which are really the solution’s brain.  Additionally, mobile/portable electronic devices are fragile and can get lost, damaged, dropped, or stolen more easily than other types of hardware that are less sexy but much more suitable in many ways.

I think it is a mistake to believe that the portability of the hardware is paramount.  And how about solutions that do not require human intervention, or devices that do not need to be operated by humans at all?  For instance, VueTrack-RF™ is VUEMED’s RFID inventory management solution that is completely hands-free and free of human intervention: the RFID antennas and the software do all the documentation, analyses, and reporting of supply chain events and transactions without any mobile devices.  Medical products manufacturers and hospitals are already looking into such non-human driven systems that are much more accurate, effective and efficient, as well as cheaper to maintain and scale up.

09/29 2014

The Pitfalls of Supply Documentation at the Point of Care

Recently at the OR Manager Conference in Long Beach, CA we held a presentation entitled “Pitfalls and Implications of Current Supply Documentation at the Point of Care.”  In it we highlighted how manual, duplicative and error-ridden this process is, and why poor point-of-care data matters – the implications of inaccurate patient medical records, poor recall and expiration tracking, over- and under-billing, and product waste, to name just a few problems.

The challenges that resonated most powerfully with our audience were: (1) the highly manual documentation process for implants and biologics; (2) items hoarding, i.e. placing products in numerous places to ensure that they won’t run out, thereby causing excess and waste; and (3) the amount of time nurses spend on reviewing and responding to billing errors the day after a procedure.

What the audience said they were most shocked to learn about was: (1) the financial impact of the errors in the clinical documentation process, and the consequences of over- and under-billing; (2) the excessive number of manual touch points in this process, from the nurses in the room to the billing clerk to the auditors and often back to the nurses; (3) how many actual pieces of paper have to be completed and tracked; and (4) to what degree this failure of supply documentation at the point of care makes it nearly impossible to track recalls to the patient.

08/14 2014

Reflecting on AHRMM14

Last week VUEMED participated in the AHRMM14 conference in Orlando. As always, AHRMM was a great opportunity to reconnect with current customers and meet potential new customers. But this year was special for us because we had the opportunity to introduce our newest technology solution, VueTrack-RF™.  We’re proud of this new milestone in our company.

VueTrack-RF™ is the RFID version of VueTrack™, using advanced ultra-high frequency RFID antennas and inexpensive, versatile passive tags. It turns any space – whether a supply room, procedure room, or warehouse – into a fully controlled inventory space using existing shelving, thereby avoiding the need to install bulky and expensive RFID cabinets. Small antennas are strategically placed on walls or in the ceilings – everything else remains the same.

A major theme at this year’s AHRMM was the critical role of the supply chain in achieving accurate and complete data. VueTrack-RF™ tracks medical supplies, assets and people in real time with 99.5% accuracy. Data capture is hands-free and virtually error-proof. Some of the benefits of VueTrack-RF™ that the healthcare providers we spoke with at AHRMM14 were particularly interested in are how it would enable them to scan any manufacturer barcode, to have access to a centrally-managed, quality controlled universal item master database, to have real-time remote access to inventory data, and to avoid costs associated with product recalls.

10/23 2013

Are you ready for the FDA’s UDI mandate?

Q: What is the FDA’s UDI mandate?

A: The FDA issued a final rule on September 24, 2013 establishing a labeling system for the identification of medical devices through distribution and use with a unique device identifier, or UDI.

Q: How will this mandate be carried out?

A: The FDA rule requires that the package of every medical device include a UDI in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology such as a barcode, RFID, etc.

Q: When will this mandate be carried out?

A: The FDA is aiming for an aggressive time table for implementation of the UDI system, with most high-risk medical devices required to carry a UDI on their label within the next year, moderate-risk devices within the next three years, and most low-risk devices within five years.

Q: What is the goal of the UDI system?

A: This system will enable the FDA to address more effectively a growing public health concern about patient injuries and deaths related to medical devices. By ensuring accurate monitoring and swift identification of devices implicated in adverse medical events, UDI will improve product recall management and patient safety.

Q: What is the GUDID?

A: GUDID is the FDA’s new public, searchable Global Unique Device Identification Database (GUDID), which the UDI will be used in conjunction with.

Q: How will this change affect healthcare providers?

A: We anticipate that healthcare providers will benefit greatly from using UDI on their devices because it will help them improve their clinical inventory management and enhance their tracking capabilities (expiration, consignment, etc). Using UDI will help provide hospitals with more accurate and efficient inventory data, the ability to implement better management tools, improved accuracy of invoices, and a reduction in the number of erroneous purchase orders.

The UDI will also be valuable for accurate clinical documentation – systematically documenting medical devices throughout the supply chain all the way to patient records.

Q: Is the FDA requiring the use of a specific type of AIDC technology?

A:  No; however, the most commonly and widely accepted form of AIDC technology is the barcode. There are currently multiple different classes of barcodes being printed on medical devices and supplies. VueTrack™ is an advanced barcode scanning technology system that is uniquely suited for reading, parsing and interpreting over 120 classes of barcodes, and for accurately and swiftly extracting the product ID, lot/serial number and expiration date. It will become vital, when embracing the UDI system, to consider upgrading at the same time to a system like VueTrack™ that can handle any barcoded information and provide a seamless feed into clinical documentation as well as materials management systems.

Q: What is new with VUEMED?

A: VUEMED has under development two new tools in beta version that leverage its unique expertise and technology applied to inventory management and clinical documentation through barcodes. The first one, VueScan™, is specifically designed to assist with the documentation process of medical devices and supplies at the point of care by allowing it to identify and parse all barcodes, and pass in real time the right information in the right data input field of the clinical documentation system, thus providing accuracy with expediency in one step. The other tool, VuePar™, is designed as an audit tool primarily for the materials management function, whose main objective is to allow actual SKU quantities available on the shelves to be periodically checked against active par levels to determine necessary reorder numbers. VuePar™ accommodates management at the SKU level but also handles the Kanban system or a combination of both, as well as consigned and non-consigned inventory.


09/05 2013

Reflecting on AHRMM 2013

If you attended the 51st Annual AHRMM Conference in San Diego recently, you might have noticed that vendors representing inventory management solutions were more numerous than in previous years. This was confirmation for me that hospitals as a whole are putting more emphasis than ever on inventory control. Also, it shows that the market is catching on and offering more options to hospitals. This is all good. The more competition there is, the better – it helps bring newer and more sophisticated solutions and technologies to the hospital environment to address the many complex issues associated with managing medical supplies and devices.

Despite an increase in the number of offerings at AHRMM, however, I didn’t see many vendors offering comprehensive solutions that address the variety of needs across the healthcare supply chain. And their lack of emphasis in most cases on the importance of complete and thorough inventory data capture surprised me, especially since hospitals are now demanding more data and analyses to help them gain better control over their inventory-related expenses.

Additionally, one thing that shocked me at the conference was the totally anachronistic approach of some consulting firms to inventory management problems. One firm was actually arguing that in a particular case study where a hospital was losing $4 million per year due to mismanaged inventory and shrinkage, it should add 30 staff people (yes, you read that right) at $50,000 per year per staff ($1.5 million total) in order to manage the inventory; their theory was that this would result in a net savings of $2.5 million per year.

The math sounds pretty attractive, but I seriously doubt that this equation could work in higher end job markets like San Francisco, NYC, Boston, and so on. Also, this solution is just out of touch with hospitals’ current reality. Who in the healthcare supply chain in recent years has been able to hire and sustain more staff? All we have been hearing lately is the mandate to do more with fewer people, not more. And can that consulting firm guarantee that spending $1.5 million on added staff really erases $4 million in shrinkage? Needless to say, this is not a sure thing.  To make matters even more ridiculous, this particular case study had to do with the waste of consigned items which weren’t even owned by the hospital (p.s. – shouldn’t the manufacturers of these products be taking some responsibility for their own inventory?).

Most importantly, we live in the 21st century, and we need to keep encouraging and supporting hospitals to modernize their processes. A much more logical and effective approach for hospitals is to invest in long-term technologies that ensure increased productivity and efficiency. By spending a little money up front on technological solutions that solve such entrenched problems as mismanaged inventory, hospitals see dramatic savings within a few short months.

05/28 2013

The Crisis of Medical Billing Practices Today

A couple of articles published in the past couple of months about hospital billing have illustrated a great crisis of our modern healthcare system in the U.S. There was the very informative but disturbing article in Time magazine in March, “Bitter Pill: Why Medical Bills Are Killing Us” by Steven Brill (, which made no apology about exposing both for-profit as well as non-profit hospitals’ mind-bending billing practices that prioritize boosting the bottom line rather than caring for patients.

The other article, published more recently earlier this month by the New York Times, “Hospital Billing Varies Wildly, Government Data Shows” (, drew attention to the disparity in cost charged to patients for identical care from one hospital to another, transcending regional variations as hospitals literally sitting across the street from each other charge vastly different amounts for the same procedure.

Both articles underscored the reality that the cost of providing care and the prices charged to patients are completely unrelated, and that hospitals follow obscure billing practices that rely on mysterious formulas. What is the true cost of care? I’m not arguing against hospitals’ charging a fair market value for their services and turning a profit. But fair market value is what’s key here – and the best interests of patients – not the financial gain of hospitals.

What I also find unnerving is that there is absolutely no transparency or guideline as to the method of pricing and charging for their services. Imagine going to a grocery store and depending on your method of payment or where that store is located, the total for your shopping cart may go from $100 to $800. In a transparent and real market economy, patients would be able to compare the price of healthcare services among providers in order to obtain the best services at the best cost. Where else do consumers engage a service without any knowledge of the price they’ll have to pay at the end? Nowhere but healthcare where patients only realize the financial trouble they’re in once they receive the bill, which can leave them anywhere from baffled to bankrupt.

Let’s give patients the power to decide where to spend their healthcare dollars. Usually when consumers are empowered, providers compete to provide the best service at the best price which should result in lower healthcare costs, more efficiency in delivering services, and increased quality and outcomes.

04/18 2013

VUEMED and Optimé Supply Chain team up

We’re very excited about our new collaboration with Optimé Supply Chain.  You may have seen on or on Yahoo! Finance that VUEMED and Optimé have joined forces to create OptiVue™, an exclusive Web-based software system that combines VueTrack™ and SmartANALYTICS™ (by Optimé).

OptiVue™ is a critically important development because it solves the data problem that exists in most hospitals. It does this by giving hospitals the tools they need to access, gather and analyze the data required to make informed decisions about their inventory composition, supply purchases, clinical utilization and comparative effectiveness.

OptiVue™ breaks down IT system silos in hospitals and creates a seamless, integrated data flow from otherwise fragmented applications, such as materials management, clinical information systems, billing and electronic medical records. OptiVue™ also connects patient, demographic and account information to the supplies used at the point of care, as well as to the performing physicians and procedure type.

For more information, check out our new OptiVue™ page on this site.